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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE
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BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE Back to Search Results
Model Number M00561221
Device Problems Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was prepared for use in the colon during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during preparation, upon checking the contents before opening the product, a foreign object was noted inside the catheter.Reportedly, there was no damage noted to the inner sterile pouch, however, the inner seal package was compromised.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
 
Event Description
It was reported to boston scientific corporation that a captivator ii-10mm round stiff snare was prepared for use in the colon during a polypectomy procedure performed on (b)(6) 2019.According to the complainant, during preparation, upon checking the contents before opening the product, a foreign object was noted inside the catheter.Reportedly, there was no damage noted to the inner sterile pouch, however, the inner seal package was compromised.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
 
Manufacturer Narrative
Block e1: the health care facility address is (b)(6).Block h6: device problem code 2944 captures the reportable event of foreign material present in device.Device problem code 1444 captures the reportable event of seal compromised.Block h10: a captivator snare was returned for analysis.Visual analysis of the returned device revealed that no damages were found on the device.The device was received with original pouch already opened and no anomalies were observed in the package.Microscope inspection was performed and a foreign material in the tip of the loop and catheter was found.Mtac inspection was also performed and the foreign material found was poly (catheter).A review of the document polypectomy snares family pfmea, bsc, cd was completed and the potential causes and controls of the related failure are documented in the risk document.Based on this review, this complaint does not represent a new or unanticipated event.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.An investigation was opened to address the failure of foreign matter present in device issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
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Brand Name
CAPTIVATOR II
Type of Device
SNARE, FLEXIBLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9150653
MDR Text Key173037028
Report Number3005099803-2019-04702
Device Sequence Number1
Product Code FDI
UDI-Device Identifier08714729855903
UDI-Public08714729855903
Combination Product (y/n)N
PMA/PMN Number
K133987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/20/2021
Device Model NumberM00561221
Device Catalogue Number6122
Device Lot Number0022975078
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2019
Date Manufacturer Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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